MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-24 for ACUFIX 479-1 manufactured by Abbott Spine.
[17256999]
In 2007 a pt was taken to the operating room to undergo revision surgery due to failure to fuse. During the revision surgery, the driver tip broke during the removal of the last 2 screws. The tip of the driver was removed without injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
[17287158]
Product is not implantable. Request has been made for product. Product investigation is pending receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649384-2007-00022 |
| MDR Report Key | 954820 |
| Report Source | 07 |
| Date Received | 2007-04-24 |
| Date of Report | 2007-04-24 |
| Date of Event | 2007-03-23 |
| Date Mfgr Received | 2007-03-30 |
| Date Added to Maude | 2007-11-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | A. MCGUIRE-GROVNER SR ANALYS |
| Manufacturer Street | 5301 RIATA PARK COURT, BLDG. F |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 5125331884 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUFIX |
| Generic Name | THREADED SCREW REMOVAL DRIVER |
| Product Code | HXY |
| Date Received | 2007-04-24 |
| Model Number | NA |
| Catalog Number | 479-1 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 925538 |
| Manufacturer | ABBOTT SPINE |
| Manufacturer Address | * AUSTIN TX * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-24 |